Job Posting: Quality Assurance (QA)
Duration: 6 Months to a year, Initial Term
Employment Type: ICQ W2
Location: Greater Boston Area
EDUCATION & EXPERIENCE REQUIREMENTS
B.S. degree in Biology, Biochemistry, Chemistry, Engineering or equivalent years’ experience working in FDA-regulated industries.
- Successfully working within a multi-disciplinary team coordinating and delivering project activities meeting schedule, budgetary and quality expectations of the client.
- Customarily and regularly exercises discretionary and independent judgment in performing the job.
- Participate in training to ensure continued accreditation.
- Maintain a safe working environment for self, team members and clients operational or administrative staff.
- Other tasks in alignment with your skills and competencies as required by the project, client and/or management.
- Must have excellent organizational, verbal and written communication skills; with demonstrated ability to efficiently and effectively communicate with cross-functional teams and management on recommended course of action, with minimal assistance.
- Must have proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint) and MS Project (as needed).
- Must be a self-starter, detail oriented and able to work independently with minimal supervision.
- Excellent troubleshooting skills; ability to react quickly to understand and solve problems.
- 3 to 5 years working in Quality Assurance Roles with experience in Bio-process manufacturing operations.
- Experience reviewing and/or approving protocols, standard operating procedures, Batch Records for process equipment used in manufacturing, troubleshooting or mitigation of discrepancies. Background or history with single use technologies is preferred.
- Direct experience providing technical assessments within the following Quality Systems: Batch Records, Deviations, Risk Assessments, CAPAs, C&Q of control systems, GMP investigation and change controls, assessing proposed changes to quality assurance process to identify requirements necessary to maintain validation status.
Please note that only local candidates will be considered.
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